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During the 1990s, IVD regulation changed dramatically, and this development has accelerated even into the new century.
Regulators and the IVD industry found agreement on quality system requirements and acceptance of ISO 13485 to cover design to post-market.1 These are major achievements and should not be undermined. Worldwide, the principles of classification of IVD medical devices, labeling requirements, risk management, and even medical event reporting have also been agreed on in principle....
The era of clinical genomics began well before the announcement by private and federally funded scientists that a draft detailing the sequence of the human genome was complete. Using what now would appear to be crude tools in the laboratory, molecular biologists made the initial transition from research to clinical diagnostics using the Southern Blot transfer analysis. This technique was used for the following purposes: (1) to identify the presence of any particular sequence in DNA isolated...
In the fifteen years since the founding of IVD Technology, the IVD industry—and its regulation by FDA—have both changed. The diagnostic capabilities of IVDs have improved dramatically during that period. Some of the advances, such as high-speed, lower-cost genomic sequencing, seemed like the stuff of science fiction when IVD Technology was first published. The number of diagnostic uses has mushroomed during that same period, and IVDs are playing an increasingly important clinical...
What a rollercoaster ride the IVD industry has been on over the last five years! Major changes on the economic, political, and scientific fronts have sent IVD manufacturers, regulators, and laboratories scrambling to cope with the new uncertainties. Every event seemed to serve as a constant reminder of the global nature of our industry.
The move toward “personalized medicine,” in part a consequence of the Human Genome Project, is finally happening. Although much more is still around...
The editors of asked top executives at some of the leading IVD companies and other key industry figures to share their vision on what the future holds for the IVD industry. Here is what these people had to say on this topic:
Diagnostics have always played a pivotal role for medical progress and better healthcare. I believe this has never been more true than today, with information becoming a key asset in healthcare. This trend is fed by novel technologies providing added information with a high...
Clinical diagnostics is changing dramatically. A revolution in bioinformatics has allowed scientists to mine the human genome to derive new and hopefully better biomarkers for some of the most pressing health problems, such as cancer, cardiac disease, diabetes, and autoimmune disorders. This development has contributed to growth in nucleic acid tests.
The next 5-10 years will see an intensification of the healthcare industry’s emphasis on informatics, wireless communications, data...
The catch-all term point-of-care (POC) testing covers an enormous range of tests in a diverse range of settings (e.g., home, doctor’s office, bedside, developing world). The main focus of this article will be the technologies behind POC testing, primarily those technologies used for immunoassay tests.
Most IVD industry experts would agree that POC testing will slowly gain greater market share and that, in particular, this is a one-way street. Tests rarely migrate back to the central lab...
An article on detection technologies that was previously published in IVD Technology’s 10th anniversary issue covered the more traditional means of developing assays that had already been commercialized and used for some time.1 That article also covered matrix-assisted laser desorption/ionization-time of flight (MALDI-TOF) technology in order to show some of the newer techniques for protein detection in human plasma and its use in tissue imaging (e.g., detection of cancerous tissues...
During the past five years, the pace of changes in IVD assay developers’ working practices has accelerated significantly. Three of the trends that were discussed in an article published five years ago in IVD Technology’s 10th anniversary issue have continued to have a direct positive impact on the development of IVD assays, which are the following: the improvement of communication among researchers; the improvement in and development of detection technologies; and the continued...
The IVD industry is infused with innovation, and the pace of discovery and development during the past 15 years has indeed been staggering. During this time period, genetic sequencing has been perfected and applied to the human genome, opening up numerous diagnostic and therapeutic opportunities. Significant advances in microfluidics and nanotechnology have enabled research lab discoveries to develop into clinical patient applications, both in the hospital and the physician’s office....
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